CLASS II Device recall · Reported 15 Apr 2020 · FDA Enforcement Report
StageOne Select, Hip Stem Cement Spacer Mold recalled by Biomet
Biomet is recalling StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, MM, Silicone, Sterile, distributed in 49 states. The recall was initiated on 26 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1644-2020
- FDA event ID
- 85153
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2020
- FDA classified
- 3 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Device type
- Hip & Knee Implants
Timeline
| 26 Feb 2020 | Recall initiated by company | |
| 3 Apr 2020 | Classified by FDA | +37 days |
| 15 Apr 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Product as listed by the FDA
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
Where it was distributed
Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Which lots are affected?
***Lot Numbers*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500, 453510, 546840, 546880, 547080, 940920, 437500, 437530, 477540, 546870, 974080, 105570, 226490, 547090, 071960, 105390, 799100R, 071940, 105470, 105550, 105460, 105480, 105510, 105520, 105430, 295490, 295500, 431310, 712100, 808020, 950370, 808030, 295470, 988850, 143520, 497700, 916880, 917200, 431520, 437530R, 478430, 478260, 478280, 478300, 478330, 478370, 478450, 518400, 518410, 518450, 518460, 478220, 570450, 639600, 639620, 639660, 639680, 639690, 644470, 661920, 661930, 661950, 662000, 261760, 261790, 276830, 661960, 661970, 661980, 662020, 518350, 661940, 696960, 696990, 455030, 570430, 639630, 661910, 696970, 697000, 697010, 697030, 813490, 813500, 845200, 845240, 845250, 845260, 845280, 845290, 845320, 845340, 845360, 877430, 877440, 877480, 877490, 877500, 063780, 084080, 037540, 063760, 171950, 210360, 210520, 210620, 772760, 777240, 788240, 806930, 838060, 894140, 028960, 900530, 330950, 364260, 073230, 465380, 488040, 554610, 605670, 605680, 623070, 641630, 673680, 673700, 673710, 673730, 689790, 689800, 758490, 810930, 810940, 834770, 834780, 834790, 885300, 518350R, 697030R, 885210, 644470R, 865720, 865730, 865770, 885240, 885270, 885280, 834810, 865750, 885220, 885250, 885310, 865670, 865700, 865740, 910020, 910060, 924640, 946710, 973850, 518420, 002310, 002320, 002330, 002340, 034900, 946720, 946730, 946750, 946760, 910040. ***UDI Numbers*** (01)00880304521230(17)160628(10)996010, (01)00880304521230(17)170328(10)795510, (01)00880304521230(17)170628(10)603900, (01)00880304521230(17)170928(10)891790, (01)00880304521230(17)171128(10)437190, (01)00880304521230(17)171128(10)735730, (01)00880304521230(17)180128(10)403040, (01)00880304521230(17)180204(10)474110, (01)00880304521230(17)180307(10)766880, (01)00880304521230(17)180306(10)819080, (01)00880304521230(17)180401(10)949560, (01)00880304521230(17)180401(10)982930, (01)00880304521230(17)180410(10)063520, (01)00880304521230(17)180509(10)277390, (01)00880304521230(17)180510(10)348170, (01)00880304521230(17)180621(10)649140, (01)00880304521230(17)180628(10)649130, 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Where was it sold?
Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
32 other products · FDA event 85153This product is part of a recall event; the main page for the event is StageOne Select, Hip Stem Cement Spacer Mold recalled by Biomet.
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| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |